Where are these Medical Device Requirements stated?

Q

QA compliance

#11
2. Our change control procedure indicates that customers will be notified if a change affects cost or delivery of their product. We were issued a nonconformance on a recent audit because our procedure does not specifically state that we would notify our customer of a change that does not affect cost or delivery. For instance, a material callout that says, "black EPDM rubber sheet 40 durometer shore A". If I switch from one supplier to another, supplying identical material that indeed meets the same spec., where does the standard state that I must notify my customer?

As far as Change Control goes, most of our customers have sent in a Change Control Agreement or else it is attached to their PO Terms and Conditions. Some of our customers also call it out in their specifications.
Hope this helps :)
 
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#12
2. Our change control procedure indicates that customers will be notified if a change affects cost or delivery of their product. We were issued a nonconformance on a recent audit because our procedure does not specifically state that we would notify our customer of a change that does not affect cost or delivery. For instance, a material callout that says, "black EPDM rubber sheet 40 durometer shore A". If I switch from one supplier to another, supplying identical material that indeed meets the same spec., where does the standard state that I must notify my customer?

As far as Change Control goes, most of our customers have sent in a Change Control Agreement or else it is attached to their PO Terms and Conditions. Some of our customers also call it out in their specifications.
Hope this helps :)
where does the standard state that I must notify my customer? Is this a new question for us to answer or merely rhetorical? My answer would be that the Standard does not require notice of substitute supplier of "fungible" product, but an individual customer contract might. Note that in USA, doctors may specify "do not substitute generic" when writing a prescription for drugs.
 
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